FOI release

Freedom of Information request (FOI 22/924)

Published 17 January 2024

FOI 22/924

27th September 2022

Dear

Thank you for your information request, dated 24 August 2022, where you asked for:

  • A copy of the letter the Medicines Control Agency sent to Sanofi on January 18 2000.
  • A copy of the letter the Medicines Control Agency sent to Sanofi on 22 July 2002.
  • A copy of any communication sent by the Medicines Control Agency with prescribers and health professionals about the potential teratogenic risks of sodium valproate and other AEDs from July to December 2002.

I can confirm that we have searched the electronic archive held by the Medicines and Healthcare products Regulatory Agency and that we do not hold copies of letters from the Medicines Control Agency to Sanofi dated January 18 2000 and 22 July 2002. We do not have a record of any communication sent by the Medicines Control Agency to prescribers and health professionals about the potential teratogenic risks of sodium valproate and other AEDs between July to December 2002. However, I attach for your information, a copy of the Medicines Control Agency bulletin “Current Problems in Pharmacovigilance” which was sent to healthcare professionals across the UK in September 2003 and includes an Article on page 6 titled ‘Sodium valproate and prescribing in pregnancy’.

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Information Commissioner’s Office

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Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

Safety and Surveillance